NCT02032485

Brief Summary

The purpose of this study is to determine if Near-Infrared fluorescence imaging is an effective approach to detect the colorectal tumoral tissues and peritoneal implants in colorectal cancer patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 colorectal-cancer

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 15, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

November 20, 2013

Last Update Submit

October 14, 2014

Conditions

Colorectal CancerPeritoneal Carcinomatosis

Keywords

colorectal cancerIndocyanine Greenvisualization of peritoneal metastases

Outcome Measures

Primary Outcomes (1)

  • fluorescence intensity of tumoral and healthy tissues after IV injection of ICG to patients with peritoneal carcinomatosis from colorectal origin.

    1 week

Study Arms (1)

Indocyanine Green

EXPERIMENTAL

Intravenous injection of 0.25 mg/kg Indocyanine Green in patients with peritoneal carcinomatosis from colorectal cancer before the surgery

Drug: Indocyanine Green

Interventions

Indocyanine GreenDRUG

An iv injection will be performed for the colorectal cancer patient before the operation.

Also known as: ICG
Indocyanine Green

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (either newly diagnosed, or relapsing) with peritoneal carcinomatosis from histo-pathologically proven colorectal carcinoma who are candidate for "open" surgery,
  • Informed consent form signed.

You may not qualify if:

  • Age less than18 years old.
  • Inability to give informed consent.
  • History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
  • Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomy of the thyroid gland.
  • Documented coronary disease.
  • Advanced renal impairment (creatinine \> 1,5mg/dl).
  • During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
  • Pregnancy, breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Jules Bordet

Brussels, Brussels Capital, 1000, Belgium

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPeritoneal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesAbdominal NeoplasmsPeritoneal Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gabriel Liberale, MD

    Surgeon in Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2013

First Posted

January 10, 2014

Study Start

March 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

October 15, 2014

Record last verified: 2014-07

Locations

BE(1)